The Effect of Palonosetron on the QTc Interval During Perioperative Period

Seoul National University

Status: Completed

Conditions: Palonosetron; Anesthesia, General

Treatments: Drug: Normal saline; Drug: Palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01650961

YSJeon_palonosetron_QTc

Details and patient eligibility

About

The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective abdominal surgery under general anesthesia

Exclusion criteria

• Cardiac valvular disease
• Clinically significant arrhythmias including atrial fibrillation
• Anti-emetics within 24 hours before surgery
• Steroids within 1 week before surgery
• Cancer chemotherapy or radiotherapy within 4 weeks before surgery
• Diabetes mellitus
• Pregnancy
• Patients receives a QT-prolonging drug

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Palonosetron

Experimental group

Description:

Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia

Treatment:

Drug: Palonosetron

Control

Placebo Comparator group

Description:

Intravenous administration of normal saline before the induction of general anesthesia

Treatment:

Drug: Normal saline